Treatment of Moderate Ischemic Mitral Regurgitation in Patients With Coronary Artery Disease

National Center for Cardiovascular Diseases

Status and phase: Enrolling; Phase 4

Conditions: Coronary Artery Disease; Ischemic Mitral Regurgitation; Angiotensin Receptor/Neprilysin Inhibitor

Treatments: Drug: sacubitril/valsartan

Study type: Interventional

Funder types: Other

Identifiers

NCT06917664

2023-I2M-C&T-B-070

Details and patient eligibility

About

This study aims to evaluate the effect of angiotensin receptor/neprilysin inhibitors (ARNI) on improving ischemic mitral regurgitation (IMR) in patients with coronary artery disease undergoing isolated coronary artery bypass grafting (CABG) through a randomized controlled clincial trial.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Fully informed and voluntarily signed informed consent;
2. Received CABG and moderate IMR was diagnosed on two consecutive preoperative transthoracic echocardiography (according to 2021 ESC/EACTS Guidance Standards )

Exclusion criteria

1.Symptomatic hypotension and/or a SBP < 100 mmHg at screening; 2.Estimated GFR < 30 mL/min/1.73m2; 3.Serum potassium > 5 mmol/L at screening; 4.History of angioedema or unacceptable side effects while receiving ACE inhibitors or ARBs; 5.Patients receiving mitral valve intervention at the same time, or have participated in other clinical trials, or are unwilling to participate in this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups

Control group: isolated CABG

No Intervention group

Sacubitril/valsartan therapy after isolated CABG

Experimental group

Treatment:

Drug: sacubitril/valsartan